Trial Outcomes & Findings for Use of Patient-Controlled Analgesia in Acute Pancreatitis (NCT NCT04816877)

NCT ID: NCT04816877

Last Updated: 2024-11-22

Results Overview

amount of time enrolled participants are admitted to the hospital.

• Recruitment status: TERMINATED
• Target enrollment: 7 participants
• Primary outcome timeframe: 4-21 days
• Results posted on: 2024-11-22

Participant Flow

The participants were recruited from a single tertiary care center. The first patient was recruited on 2/22/2022 and the last patient on 10/17/2023.

All the 7 patients underwent assignment to both the treatment groups

Participant milestones

Measure	Patient Controlled Analgesia (PCA) Group Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Overall Study STARTED	3	4
Overall Study COMPLETED	2	4
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Patient Controlled Analgesia (PCA) Group Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Use of Patient-Controlled Analgesia in Acute Pancreatitis

Baseline characteristics by cohort

Measure	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Total n=7 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	58 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 4-21 days

amount of time enrolled participants are admitted to the hospital.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Length of Stay (Days)	12 days Standard Deviation 4	9.75 days Standard Deviation 5.5

SECONDARY outcome

Timeframe: From date of hospital admission to discharge, assessed up to 12 days

The duration of time between patient presentation and dietary advancement was noted.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Number of Days the Patient Gets Nothing by Mouth (NPO) Before Diet is Initiated	3 days Standard Deviation 0	6.25 days Standard Deviation 7.8

SECONDARY outcome

Timeframe: Day 1 of hospitalization and Average Pain Score throughout entire hospital stay, assessed up to 12 days

Mean pain scores over the first 24 hours, second 24 hours, and course of their hospital stay were recorded using a numeric rating scale which ranged from 0 to 10 where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Mean Pain Scores on a Numeric Rating Scale (NRS) Over the First 24 Hours and Over Entire Course of Their Hospital Stay Mean NRS over 24 hrs	5.5 units on a scale Standard Deviation 0	5.6 units on a scale Standard Deviation 3.14
Mean Pain Scores on a Numeric Rating Scale (NRS) Over the First 24 Hours and Over Entire Course of Their Hospital Stay NRS over entire stay	2.1 units on a scale Standard Deviation 0	7 units on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: Through hospital stay, an average of 5-7 days

The total opioid dose for pain control was quantified through Total morphine milligram equivalent which was calculated based on the standardized conversion of opioids.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Total Morphine Milligram Equivalent	110 morphine milligram equivalents Standard Deviation 0	291 morphine milligram equivalents Standard Deviation 324.8

SECONDARY outcome

Timeframe: Through hospital stay, an average of 5-7 days

The time from the transition of IV opioids to PO opioids was recorded.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Time to Transition to PO Opioids	2 days Standard Deviation 0	7.67 days Standard Deviation 8.9

SECONDARY outcome

Timeframe: Through hospital stay, an average of 5-7 days

Opioid-related adverse events were prospectively collected.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=4 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=3 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Number of Participants With Opioid-related Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through hospital stay, an average of 5-7 days

Use of naloxone and antiemetics was noted for each recruited subject.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Number of Participants With Use of Naloxone and Antiemetics	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through hospital stay, an average of 5-7 days

Transfer of patients to the intensive care unit was prospectively noted.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Number of Participants With ICU Transfer	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

The 30-day readmission rates were prospectively noted.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Number of Participants With 30-day Readmission	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Through hospital stay, an average of 5-7 days

All-cause inpatient mortality and opioid-related inpatient mortality were recorded.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
All-cause Inpatient Mortality and Opioid-related Inpatient Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

30-day mortality was prospectively noted.

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=4 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=3 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
30-day Mortality	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Through hospital stay, an average of 5-7 days

Daily morphine milliequivalents on discharge were recorded prospectively

Outcome measures

Measure	Patient Controlled Analgesia (PCA) Group n=3 Participants Patients in this group will be allocated to the PCA arm, i.e., they will be receiving a PCA pump for administration of opioids. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.	Physician Directed Analgesia (PDA) Group n=4 Participants Patients in this group will be allocated to the PDA arm, i.e., they will be receiving opioids administered by the nurse, as and when directed by the physician. Opioid: Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
Daily Morphine Milliequivalents on Discharge	15 morphine milligram equivalents Standard Deviation 25.8	11.25 morphine milligram equivalents Standard Deviation 22.5

Adverse Events

Patient Controlled Analgesia (PCA) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physician Directed Analgesia (PDA) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sunil Sheth

Beth Israel Deaconess Medical Center

Phone: 6176675576

Email: ssheth@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place